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FDA Hydrocodone Recommendation Was Long Opposed by Business, Patient Groups


Business and patient groups waged a costly lobbying campaign against tighter prescribing regulations for hydrocodone products for many years, according to The New York Times. Last week, the Food and Drug Administration (FDA) recommended tighter restrictions for products containing hydrocodone and other painkillers such as acetaminophen or aspirin. These combination products include Vicodin and Lortab.

The newspaper described the FDA’s decision as “a rare victory by lawmakers from states hard hit by prescription drug abuse over well-financed lobbyists for business and patient groups.”

Currently, patients can refill prescriptions for hydrocodone products five times over a six-month period before they need a new prescription. Under the new FDA regulations, patients will only be able to receive a 90-day supply of the medication without a new prescription. According to federal data, most patients only take the drugs for about two weeks, creating the potential for extra pills to be sold or taken by teens who find them in the medicine cabinet. The new rules will also require patients to take a prescription to a pharmacy, instead of having a doctor call it in.

These changes are expected to take place as early as next year. They first must be approved by the Department of Health and Human Services and adopted by the Drug Enforcement Administration, which has long advocated for stronger regulations for prescribing hydrocodone products.

Last year, Representative Fred Upton of Michigan, who received almost $300,000 in drug industry campaign contributions, blocked a measure that would have required the same restrictions the FDA recommended last week. Upton said limiting hydrocodone prescriptions would harm patients who needed the drugs. The same argument has been made by patient groups, lobbyists representing drug manufacturers, large pharmacy chains and physician groups including the American Medical Association.

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